the efficacy and safety of intracranial self-expanding des in symptomatic intracranial atherosclerotic disease

Conditions: Intracranial Arterial Diseases; Stent Restenosis; Percutaneous Transluminal Angioplasty

Summary: the primary objective of this trial is to evaluate the safety and efficacy of sinomed is- des in patients with symptomatic intracranial atherosclerotic stenosis.

this study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of intracranial self-expanding drug stent system in the treatment of symptomatic intracranial atherosclerotic stenosis. a total of 128 patients are planned to be included. the primary endpoint is the incidence of in-stent restenosis at 6 months after operation (isr is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.). all patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.

Eligibility criteria:
inclusion criteria: 1. 30 to 75 years of age; 2. patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery; 3. digital subtraction angiography(dsa) showed 70% to 99% stenosis in target intracranial artery 4. the target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment; 5. the target lesion reference diameter must be visually estimated to be ≥2.0 mm and \<4.5mm in diameter, and lesion length of ≤34 mm; 6. mrs \< 3; 7. the onset of the latest transient ischemic attack (tia) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure; 8. willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow-ups, etc. according to the requirements of the clinical protocol during the clinical trial. exclusion criteria: 1. the target vessels was complete occlusion; 2. \>70% stenosis observed at the intracranial large-vessel distal to the target vessel or \>70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel; 3. preoperative magnetic resonance only showed perforating infarction in the target lesion area; 4. preoperative ct or mri showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment chronic subdural hematoma ≥5mm; 5. hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery; 6. ct showed severe calcified lesions; 7. previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation); 8. non-atherosclerosis lesions; 9. patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks); 10. concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation; 11. known hypersensitivity to aspirin, heparin, clopidogrel, rapamycin (sirolimus), lactic acid polymer, poly-n-butyl methacrylate, nickel-titanium alloy, or contraindications to anesthetics and contrast agents; 12. hemoglobin \ 1.5 (irreversible) or uncorrectable hemorrhagic factors; 13. uncontrollable severe hypertension (systolic blood pressure\>180mmhg or diastolic blood pressure\>110mmhg)； 14. known liver or renal insufficiency (alt\> 3x upper limit or ast \> 3x upper limit, serum creatinine\>250μmol/l); 15. life expectancy \< 1 year; 16. pregnant/lactating female patients; 17. patients with cognitive impairment or mental diseases (except for those with cognitive impairment due to arterial stenosis); 18. patients who were participated in other clinical trials within 3 months or participating in other clinical trials who had not yet reached the primary clinical endpoint; 19. inapplicable for intravascular stenting treatment as per investigators judgment.

Keywords: self-expanding intracranial stent symptomatic intracranial atherosclerotic disease in-stent restenosis